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The Senior Software Test Engineer will focus on supporting medical device software testing for the Embedded System. The position is a hands-on test development & individual contributor role with a dynamic set of responsibilities in a complex software system including test design & development, design of test automation framework, test scripts development and test execution.

Responsibility

· Design, implement, execute, and document test software using manual and/or automation methodologies.

· Thoughtfully develop testing strategies and protocols with state-of-the-art software best practices.

· Develop test strategies, review test designs, and validate test scripts, verification of software for Embedded Medical System.

· Provide support for NPTV (Non-product tool validation).

· Navigate the complexities of industry and government regulations to include IEC62304 and FDA QSR (Quality System Regulation) requirements.

· Develop, document, and test software to ensure that the software meets the needs of end-users and achieves business goals.

· Provide assistance to development teams.

· Commitment to achieving and exceeding project goals and timelines.

· Thrives in working with other disciplines to develop system-minded implementations that consider safety, performance, communication, user interface and other aspects of a final Medical Device product.

· Work in a cross-functional Agile team across global R&D teams to test software for new and existing medical device products.

· Participate in reviews of requirements, design, implement and test to ensure quality standards are met

· Analyze unexpected, undesirable, or non-understood behavior in software and in interactions of software with hardware.

· Document results of defect analysis.

· Follow the IEC 62304 standard and project documents such as the software development plan and coding standards.

· Participates in other quality assurance functions, including, but not limited to, static code analysis, risk/hazard analysis, and test automation development.

· Should be an excellent team player with good communication skills.

· Should meet key business KPI/project metrices.

QUALIFICATIONS

· Bachelor’s degree in computer science & Electronics & Communication or related engineering discipline.

· 8 to 12 years’ experience in Embedded Software V&V with at least 4 years’ experience in the medical device or regulated industry.

KNOWLEDGE, SKILLs, AND ABILITY:

· Knowledge in atleast one of the programing language. i.e. C,C++,python using Embedded development environment.

· Experience on both white box and black box testing.

· Solid hands on with Automated, semi-automated & manual testing

· Experience in hardware/software interfacing and design issues.

· Experience in Agile tools & technology

· Experience in test automation preferably using Python.

· Participate in System design, coordination with teams and internal product management.

· Know-how of field-bus technology and standard Embedded communication protocols (DDS, SPI, I2C, AXI, UART, etc.)

· Excellent debugging skills and problem-solving capabilities

· Experience working in a structured software development environment following a well-defined software development process like Agile / Lean.

· Experience with software risk analysis (per ISO 14971) including software failure mode and effects analysis (FMEA).

· Must be a great individual contributor and team player.

· Must have qualities including being positive, high standards, resilient, open, and creative.

· Awareness of Medical Device standards IEC 60601-1, IEC 62304, ISO 13485, ISO 14971, and applicable FDA standards

· Appreciation of discipline and work required to develop software in a regulated industry

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It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.